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Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

Pages: 592

Publisher: Wiley

Year of Publication: 2019

Author(s) : David Roesti (Editor), Marcel Goverde (Editor)

Book Description:

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.

  • Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC
  • Presents the latest developments in both regulatory expectations and technical advancements
  • Provides guidance on statistical tools for risk assessment and trending of microbiological data
  • Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
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